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12:00 AM
Aug 06, 2012
 |  BioCentury  |  Strategy

Freedom to deal Strategy

Where Idenix might fit into HCV landscape after unwinding Novartis deal

Idenix Pharmaceuticals Inc. believes it is finally positioned to become a player in the race for an all-oral HCV regimen after restructuring its nine-year old collaboration with Novartis AG. But by now several large HCV companies have made their plays.

The deal amendment announced last week terminates Novartis' option to license current and future Idenix compounds.

Two days later, the biotech raised $176 million to start multiple combination trials of its own HCV candidates.

The tie-up between Idenix and Novartis started in May 2003, when the pharma acquired a 54% stake for $255 million. The deal gave Novartis an option to license any Idenix compound upon completion of proof-of-concept trials. The partners were to co-promote and equally share profits from products in the U.S. and five major EU markets.

Novartis also paid $75 million to license two HBV programs, Tyzeka telbivudine and valtorcitabine. The HBV-selective nucleosides were Idenix's lead programs at the time. Tyzeka was approved in the U.S. in 2006 and Europe in 2007.

The ownership stake also gave Novartis corporate governance rights, allowing it to exercise control over the biotech's strategic direction, R&D activities and ability to raise money.

Outside of Tyzeka, the partnership had borne little fruit. In 2006, Novartis exercised its option for valopicitabine, a ribonucleoside analog in Phase IIb trials for HCV. But a year later the program was placed on clinical hold and subsequently discontinued based on the overall risk-benefit profile.

In October 2007, the partners amended their deal, giving Novartis full responsibility for manufacturing and commercializing Tyzeka. Idenix restructured to focus on its HCV and HIV programs and discontinued valtorcitabine for HBV because of disappointing Phase IIb data in combination with Tyzeka.

Then, in 2009, Novartis decided not to exercise its option for Idenix's lead HCV program, IDX184, a nucleotide HCV NS5B polymerase inhibitor. The pharma did not provide a reason.

Right at the time

"The Novartis agreement was right for that time," Idenix President and CEO...

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